Anktiva Solution
NDC Package 81481-803-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Anktiva (nogapendekin alfa inbakicept-pmln) solution is aNKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. This formulation utilizes a solution delivery system. Marketed by Altor Bioscience, Llc, An Indirect Wholly-owned Subsidiary Of Immunitybio, Inc., this product is identified by NDC 81481-803 and is authorized under FDA application BLA761336.

Identification & Billing

NDC Package Code
81481-803-01
Package Description
1 VIAL, GLASS in 1 BOX / .4 mL in 1 VIAL, GLASS
Product Code
11-Digit Billing Format
81481080301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2682684 - nogapendekin alfa inbakicept-pmln 400 MCG in 0.4 ML Intravesical Solution
  • RxCUI: 2682684 - 0.4 ML nogapendekin alfa inbakicept-pmln 1 MG/ML Intravesical Solution
  • RxCUI: 2682684 - nogapendekin alfa inbakicept-pmln 400 MCG per 0.4 ML Intravesical Solution
  • RxCUI: 2682691 - Anktiva 400 MCG in 0.4 ML Intravesical Solution
  • RxCUI: 2682691 - 0.4 ML nogapendekin alfa inbakicept-pmln 1 MG/ML Intravesical Solution [Anktiva]

Clinical Specifications

Proprietary Name
Anktiva
Non-Proprietary Name
Nogapendekin Alfa Inbakicept-pmln
Substance Name
Nogapendekin Alfa Inbakicept-pmln
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Intravesical - Administration within the bladder.
Usage Information
ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Regulatory & Marketing

Labeler Name
Altor Bioscience, Llc, An Indirect Wholly-owned Subsidiary Of Immunitybio, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761336
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-06-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J9028
Source: ASP
Inj, nogapendekin pmln, 1mcg
HCPCS Dosage 1 MCG
Units / Pkg 400

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 81481-803-01 identifies a specific commercial package of 1 vial, glass in 1 box / .4 ml in 1 vial, glass of Anktiva, a human prescription drug labeled by Altor Bioscience, Llc, An Indirect Wholly-owned Subsidiary Of Immunitybio, Inc.. This solution is formulated for intravesical use and contains nogapendekin alfa inbakicept-pmln as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Altor Bioscience, Llc, An Indirect Wholly-owned Subsidiary Of Immunitybio, Inc. on May 06, 2024. The current certification is valid through December 31, 2026.

How is this Altor Bioscience, Llc, An Indirect Wholly-owned Subsidiary Of Immunitybio, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81481080301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
81481-803-01
11-Digit CMS (5-4-2)
81481-0803-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.